A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)



Status:Completed
Conditions:Constipation, Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:2/7/2015
Start Date:July 2013
End Date:December 2014
Contact:Lennie Wu, Master
Phone:86-2038183761

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This clinical trial is an international, multicenter, randomized, double-blind,
placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo.
Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be
randomized at up to 60 trial centers in China, Australia, and New Zealand.

The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12
weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment
Period, patients meeting the entry criteria for this trial will be randomized to one of two
double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).


Inclusion Criteria:

1. Patient has signed an Informed Consent Form(ICF).

2. Patient Must not be pregnant or breastfeeding and agree to use birth control

3. Patient meets the colonoscopy requirements defined by the American
Gastroenterological Association guidelines and no clinically-significant laboratory
or physical examination findings;

4. Patient meets protocol-defined criteria for Irritable Bowel Syndrome with
Constipation(IBS-C), including stool frequency, straining, stool consistency,
abdominal pain, and abdominal discomfort criteria

5. Patient meets protocol-defined eDiary completion Compliance and agrees to refrain
from making any new, major life-style changes that may affect IBS-C symptoms

Exclusion Criteria:

1. Recent history of mushy or watery stools

2. Various medical conditions, medical histories, or family medical histories that would
not make the patient a good candidate for the study

3. Patient currently has both unexplained and clinically significant alarm symptoms or
systemic signs of infection or colitis.

4. Surgery to the gastrointestinal tract

5. Usage of prohibited medications
We found this trial at
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